MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR PTA BALLOON DILATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK722

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon circumferential tear occurred.The target lesion was located in a vessel of the arm.Approximately two months ago, a gladiator balloon catheter was selected for use and advanced for dilation.However, during the procedure, the balloon had circumferential tear and the physician had to do a cut down to the vessel to completely retrieve the balloon from the patient's body.The procedure was not completed.No further patient complications were reported and the patient's status is fine.

• Brand Name: GLADIATOR PTA BALLOON DILATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5288703
• MDR Text Key: 33255126
• Report Number: 2134265-2015-08550
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention